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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Product CodeLXT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
NEW PARADIGM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 40 40
2020 32 32
2021 24 24
2022 21 21
2023 18 18
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 26
Break 23 23
Migration 14 14
Appropriate Term/Code Not Available 12 12
Mechanical Problem 11 11
Device-Device Incompatibility 10 10
Packaging Problem 8 8
Migration or Expulsion of Device 7 7
Connection Problem 5 5
Difficult to Insert 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Deformation 4 4
Crack 3 3
Fracture 3 3
Shipping Damage or Problem 2 2
Device Slipped 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Loss of Osseointegration 1 1
Malposition of Device 1 1
Insufficient Information 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
No Known Impact Or Consequence To Patient 24 24
No Code Available 24 24
Failure of Implant 17 17
No Patient Involvement 13 13
Pain 9 9
Non-union Bone Fracture 7 7
Unspecified Infection 6 6
No Consequences Or Impact To Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 4 4
Unspecified Tissue Injury 2 2
Injury 2 2
Post Operative Wound Infection 2 2
Loss of Range of Motion 2 2
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Discomfort 1 1
Osteolysis 1 1
Impaired Healing 1 1
Osteopenia/ Osteoporosis 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Skin Infection 1 1
Physical Asymmetry 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. II Jun-28-2022
2 Zimmer Biomet, Inc. II Jan-10-2019
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